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The efficacy comparison of fluoxetine and citalopram on motor recovery after ischemic stroke: single-blind placebo-controlled randomized clinical trial

Protocol summary

Study aim
Comparison of the efficacy of fluoxetine and citalopram on the improvement of motor function after ischemic stroke
Design
A randomized, randomized, phase 3 clinical trial in 90 patients was used to randomize the random function of Excel software.
Settings and conduct
Giving the patient matched capsules to compare the effectiveness of citalopram and fluoxetine on improving motor function after ischemic stroke, the site of intervention at Ayatollah Rouhani Hospital - a single-blind clinical trial with blind participants
Participants/Inclusion and exclusion criteria
The study population includes patients who are admitted to Ayatollah Rouhani Hospital with a diagnosis of ischemic stroke. Inclusion criteria include age over 18 - Hemiplegia or hemiparesis after the first ischemic stroke in the last 24 hours. Withdrawal conditions, including patients with ischemic stroke, initially lost consciousness and were admitted to the ICU. The patient has a history of psychiatric disorders. Having movement disorders before stroke, pregnancy and lactation, patients receiving psychiatric medication. Existence of any therapeutic contraindications such as renal failure (GFR) below 30 and impaired liver function tests, hyponatremia, long QT interval. Occurrence of any significant drug side effects during treatment such as restlessness, hypertension or symptoms of serotonin syndrome
Intervention groups
Group A, which consists of 30 people, is treated with fluoxetine, group B, which consists of 30 people, is treated with citalopram, and group C, which is the control group, is treated with placebo. In addition to the standard treatments for ischemic stroke for all three groups.
Main outcome variables
Age - Gender - Blood pressure - Total dose of prescribed drug - Motor score of NIHSS motor scale

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210307050617N1
Registration date: 2021-03-27, 1400/01/07
Registration timing: registered_while_recruiting

Last update: 2021-03-27, 1400/01/07
Update count: 0
Registration date
2021-03-27, 1400/01/07
Registrant information
Name
Fatemeh Karimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3219 2034
Email address
karimif632@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-26, 1400/01/06
Expected recruitment end date
2021-12-22, 1400/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy comparison of fluoxetine and citalopram on motor recovery after ischemic stroke: single-blind placebo-controlled randomized clinical trial
Public title
Comparison of the effect of fluoxetine and citalopram on motor recovery after ischemic stroke, single-blind clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years Hemiparesis or hemiplegia after the first ischemic stroke in 24 hours A score greater than 2 NIHSS scale motion items
Exclusion criteria:
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Balanced (permuted) block randomization with a block size of 30 people and three groups ( A,B,C ).
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients in this study are blind . In this way drugs and placebo are poured into the capsule to match the same size and color, the capsules of each group are poured into cans and given to patients, and the patient is unaware of the type of drug. And the doctor knows what kind of medicine the patient has received (fluoxetine group A, citalopramgroup B, placebo group C ) which is recorded in the patient's demographic information question.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Babol University of Medical Sciences
Street address
Rouhani hoapital, Ganjafroz street, Babol, Mazandaran
City
Babol
Province
Mazandaran
Postal code
4717647745
Approval date
2020-08-22, 1399/06/01
Ethics committee reference number
IR.MUBABOL.REC.1399.279

Health conditions studied

1

Description of health condition studied
Ischemic stroke
ICD-10 code
I63.9
ICD-10 code description
Cerebral infarction, unspecified

Primary outcomes

1

Description
Evaluate the rate of improvement in motor function after receiving the drug after one, two and three months
Timepoint
The patient's motor function is measured every month. The study time on each case is 90 days
Method of measurement
Using the NIHSS scale motion item

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: The first intervention group is group A, which has 30 patients.They are given fluoxetine capsules made by Aria Company at a dose of 20 mg daily for three months, and at the end of the first, second and third months, the rate of subsequent motor function improvement is evaluated in patients based on the NIHSS motor scale and drug side effects.
Category
Treatment - Drugs

2

Description
Intervention group 2: The second group of intervention is group B. The number of patients in this group is 30. The patients are given citalopram tablets made by Sobhan Pharmaceutical company at a dose of 10 mg in the first 10 days and then 20 mg daily ( which are poured into a capsule to be matched with a fluoxetine capsule) for 3 months.The NIHSS motor scale and drug side effect are assessed at the end of the first, second and third months.
Category
Treatment - Drugs

3

Description
Control group: This group is called group C, which has 30 patients. in addition to the standard treatment for ischemic stroke, placebo, which is starch and is poured into a capsule for assimilation with fluoxetine and citalopram, is given to one capsule daily for 3 months. At the end of the first, second and third months, the rate of improvement in motor function is assessed based on the NIHSS movement scale.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatollah Rouhani hospital ( Babol university of medical sciences)
Full name of responsible person
Fatemeh Karimi
Street address
Rouhani hospital, Ganjafroz Street, Babol,Mazandaran
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 2034
Email
KARIMIF632@GMAIL.COM

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Babaei
Street address
Rouhani hospital, Ganjafroz Street, Babol,Mazandaran
City
Babol
Province
Mazandaran
Postal code
47176447745
Phone
+98 11 3219 2034
Email
KARIMIF632@GMAIL.COM
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
University
Proportion provided by this source
1
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Payam Saadat
Position
Neurologist and University faculty
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Rouhani hospital, Ganjafroz street, Babol, Mazandaran
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 2034
Email
sepanta1968@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Payam Saadat
Position
Neurologist and faculty member of Babol University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Rouhani hospital, Ganjafroz street, Babol, Mazandaran
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 2034
Email
sepanta1968@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Fatemeh Karimi
Position
Medical Intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Rouhani hospital, Ganjafroz street, Babol, Mazandaran
City
babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 2034
Email
karimif632@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Part of the data, such as information about the main outcome of the study, which is the rate of improvement in motor function, and its dependent variables
When the data will become available and for how long
After completing the study and after publishing the article
To whom data/document is available
Researchers working in academic centers
Under which criteria data/document could be used
The rate of improvement of motor function and analysis of related variables, evaluation of side effects
From where data/document is obtainable
Email the person in charge and the facilitator
What processes are involved for a request to access data/document
Request a study by email and provide sufficient evidence that the applicant is a university researcher.
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